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Pregnancy Complications clinical trials

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NCT ID: NCT06468202 Not yet recruiting - Preeclampsia Clinical Trials

Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

ASPIRIN
Start date: December 1, 2024
Phase: Phase 4
Study type: Interventional

The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.

NCT ID: NCT06452498 Not yet recruiting - Pre-Eclampsia Clinical Trials

Preeclampsia Intervention Netherlands

PI-NL
Start date: August 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands. Signs of preterm PE can be high blood pressure and protein in the urine in the second half of pregnancy (but before 32-34 weeks of pregnancy). Other symptoms can develop, such as problems with blood clotting and how well the blood cells, liver, lungs, and brain work. The disease can lead to serious complications for both the mother and child. The only way to cure preterm PE is to make sure the child is born, and many times, children have to be delivered (very) early (before 37 weeks). Children born (very) early can suffer from infections, breathing difficulties, and problems in their development. Metformin is a medicine used to treat high blood sugar during and outside of pregnancy. In a previous study in South Africa, women with preterm PE that used metformin were able to safely remain pregnant for an extra week. Similarly, the main goal of the Preeclampsia Intervention NetherLands (PI-NL) study is to see if patients with preterm PE in the Netherlands that use metformin can remain pregnant for a longer time than patients taking a placebo. A placebo is a look-a-like capsule that contains no active ingredients. Researchers, the treating medical team, and participants will not know which participant gets which treatment. In addition, all participants will receive the standard care that all preterm PE patients get.

NCT ID: NCT06445543 Not yet recruiting - Clinical trials for Gestational Hypertension

Nutrition Optimization and Community Upliftment for Postpartum Recovery: Intervention to Support Healing After Hypertensive Disorders of Pregnancy

NOURISH-HDP
Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to better understand how different strategies, timing, and enhancements to medically tailored food delivery will address structural inequities in the food environment, empower communities to sustain behavior change, and ultimately improve postpartum weight control to prevent chronic hypertension-a potent contributor to disparate mortality among Black women. - To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, MFeast ENHANCED (a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery, customized for postpartum people, culturally customized for engagement and adherence, and food provision for dependents) versus MFeast Usual Care (prepared medically tailored foods only). - To test sustainability and scalability. Participants will: - Respond to online surveys (supported by study team members via scheduled phone calls) via REDCap links shared before each study visit at baseline, 3 and 6 months post-delivery after the baseline survey. - Submit anthropometric data (e.g. weight and blood pressure)

NCT ID: NCT06445270 Not yet recruiting - Clinical trials for Gestational Diabetes

Evidence-informed Trial of Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals

Start date: April 2025
Phase: N/A
Study type: Interventional

The goal of this study is assess the impact of a higher intensity dietary and activity counseling program to improve blood sugar control and reduce the chance of developing gestational diabetes (GDM) as compared to the current standard diet and activity counseling.

NCT ID: NCT06430853 Not yet recruiting - Mental Health Issue Clinical Trials

Psychobiological Interventions in Pregnancy

PIP
Start date: September 2024
Phase: N/A
Study type: Interventional

This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.

NCT ID: NCT06415942 Not yet recruiting - Maternal Death Clinical Trials

Assessing the Maternal Outcome Monitoring Systems

MOMS
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.

NCT ID: NCT06385366 Not yet recruiting - Preterm Birth Clinical Trials

Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test

Start date: May 15, 2024
Phase:
Study type: Observational

This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam.

NCT ID: NCT06374199 Not yet recruiting - Clinical trials for Pregnancy Complications

Med-South Lifestyle Program for Pregnancy

Start date: April 2024
Phase: N/A
Study type: Interventional

Eating a Mediterranean-style diet during pregnancy improves pregnancy outcomes, yet most Americans who are pregnant do not follow this type of dietary pattern. There is increasing interest in Food is Medicine programs, which provides foods to patients to improve health outcomes - food provided in this context is called medically tailored meals. The research team at the UNC Center for Health Promotion and Disease Prevention is developing a Food is Medicine program to improve pregnancy outcomes and at this point the team is ready to test the program. The purpose of this study is to assess the feasibility and acceptability of a Food is Medicine intervention when started during the first trimester of pregnancy. The eating pattern to be evaluated in this study is a Mediterranean-style dietary pattern adapted for the southern United States - thus, the program is called "Med-South." All who take part will receive Med-South dietary counseling. In addition, to help participants follow a Med-style dietary pattern, one group of study participants will receive extra virgin olive oil and nuts. The other group will receive extra virgin olive oil, nuts, and frozen meals (medically tailored meals) that align with the Med-South dietary pattern. Participants will be assigned at random (like flipping a coin) to one of these groups

NCT ID: NCT06366659 Not yet recruiting - Clinical trials for Intrahepatic Cholestasis of Pregnancy

Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy

Start date: April 20, 2024
Phase:
Study type: Observational

This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP.

NCT ID: NCT06357962 Not yet recruiting - Clinical trials for Pregnancy Complications

Semi-permanent Acupuncture Effect on Cervical Ripening

Start date: September 2024
Phase: N/A
Study type: Interventional

Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture.